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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameDURASOFT4 (OFILCON A) SPHERICAL HYDROPHILIC LENS
Classification Namelenses, soft contact, daily wear
Generic Nameofilcon a spherical hydrophilic lenses
Regulation Number886.5925
ApplicantCIBA VISION CORPORATION
PMA NumberP850072
Date Received09/30/1985
Decision Date07/17/1986
Withdrawal Date 05/12/2009
Product Code
LPL[ Registered Establishments with LPL ]
Docket Number 86M-0325
Notice Date 08/14/1986
Advisory Committee Ophthalmic
Expedited Review Granted? No
Combination Product No
Supplements: S001 S002 S003 S004 S005 S006 
S007 
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